Our Advisory Services
Specialist clinical and regulatory advisory support for medical device manufacturers across international registration programs .
Clinical Investigation Advisory
Strategic guidance on clinical investigation design, ethics committee submission strategy, site activation planning and protocol structure.
Regulatory Strategy Advisory
Guidance on regulatory sequencing, submission pathways and coordinated EU MDR and NMPA registration strategies.
Market Access Planning
Strategic support for market access planning, stakeholder engagement and commercial positioning across target markets.
Investigator Site Network
Access to established investigator and ethics committee relationships across Turkey and European markets.
Technical Documentation Advisory
Advisory review of technical files, clinical evaluation reports and regulatory submission dossiers.
Compliance & Audit Advisory
Advisory support for PMS obligations, QMS alignment, Notified Body interaction and audit preparation.
Training
Professional medical education programmes including cadaver workshops, live demonstrations and supervised practical training in aesthetic medicine
International Regulatory Coverage
Our advisory perspective spans key international regulatory frameworks, supporting medical device manufacturers in planning efficient and coordinated pathways across multiple markets.
Our areas of focus include EU MDR 2017/745, NMPA China, ISO 14155 / GCP and selected APAC markets, including Taiwan, South Korea, Australia and Singapore.
Why Neo Plus Medical
EU MDR-Aligned Clinical Environment
Turkey offers a strong clinical investigation environment aligned with EU MDR standards.
Established Investigator Network
Established investigator and ethics committee relationships across key markets.
Specialist Class III Expertise
Specialist expertise in aesthetic injectables and Class III medical devices
Our Approach
01 — Programme Assessment
Advisory review identifying gaps, sequencing opportunities and key risk factors.
03 — Ongoing Advisory
Continuous advisory support as the programme advances and regulatory requirements evolve.
02 — Strategy Development
Structured advisory input on investigation design, submission sequencing and authority engagement.
04 — Approval Readiness
Assessment of submission readiness and recommendations for securing regulatory approval.